QA - Reviewer(Freshers)

Job Summary

The QA Reviewer is responsible for reviewing analytical data, laboratory records, test reports, and quality documentation to ensure compliance with NABL (ISO/IEC 17025), USFDA, GLP, GMP, and internal quality requirements. The role involves ensuring data integrity, documentation compliance, method validation review, audit readiness, CAPA management, and quality system implementation. ISO/IEC 17025 laboratories are expected to maintain documented management systems, internal audits, corrective actions, and management reviews, which the QA Reviewer helps oversee.

Key Responsibilities

Quality Review & Documentation

• Review analytical raw data, chromatograms, calculations, worksheets, and test reports.
• Verify compliance of laboratory records with SOPs, STPs, protocols, and regulatory requirements.
• Review Certificates of Analysis (COA), test reports, and validation reports before release.
• Ensure data integrity compliance (ALCOA+ principles).

NABL & Regulatory Compliance

• Ensure compliance with NABL accreditation requirements and ISO/IEC 17025 standards.
• Support laboratory accreditation, surveillance audits, and reassessment activities.
• Review quality system documents, SOPs, forms, specifications, and protocols.
• Monitor compliance with laboratory quality management systems and internal audit requirements.

Method Validation & Verification

• Review method validation, method verification, method transfer, and stability study reports.
• Verify accuracy, precision, linearity, robustness, and other validation parameters.
• Ensure analytical methods comply with applicable regulatory guidelines.

Audit & Inspection Readiness

• Participate in internal audits, external audits, customer audits, and regulatory inspections.
• Assist in preparation for NABL and USFDA inspections.
• Review audit observations and ensure timely closure of corrective actions.

CAPA & Quality Systems

• Investigate deviations, OOS, OOT, incidents, and customer complaints.
• Prepare and review CAPA documentation and effectiveness checks.
• Track quality metrics and support continuous improvement initiatives.

Training & Compliance

• Conduct training on SOPs, quality systems, data integrity, and regulatory requirements.
• Ensure laboratory personnel comply with approved procedures and quality standards.

Required Skills

• Strong knowledge of NABL (ISO/IEC 17025) requirements.
• Understanding of USFDA, GMP, GLP, and Data Integrity guidelines.
• Experience in analytical data review and documentation review.
• Knowledge of method validation and laboratory quality systems.
• Good understanding of CAPA, OOS, deviations, and audit management.
• Proficiency in MS Office and Laboratory Information Management Systems (LIMS).Role & responsibilities

Preferred candidate profile